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临床试验/NCT00962429
NCT00962429已完成2 期

Lipoic Acid for Chronic Inflammatory Demyelinating Polyneuropathy-A Randomized, Double-Blind, Placebo Controlled Pilot Study

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
7
试验地点
1
主要终点
Muscle Strength

研究概览

简要总结

The purpose of the study is to examine if alpha lipoic acid is an effective treatment for chronic inflammatory demyelinating polyneuropathy (CIDP).

详细描述

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a progressive disease leading to paralysis. CIDP is an immune-mediated disorder resulting from a synergistic interaction of T cell-mediated and B cell-mediated immune responses directed against peripheral nerve antigens. These immune mediated responses in turn increase the production of reactive oxygen intermediate and cause oxidative damage of the peripheral nerve system. Although corticosteroids, plasma exchange, and intravenous immunoglobulin (IVIg) reduce impairment caused by CIDP at least temporarily and can be used as a first-line treatments, they are not ideal for long-term treatment because of serious side effects and cost. Alpha lipoic acid (LA) is an antioxidant that also possesses anti-immune activity. It is effective in treating diabetic neuropathy. It is also promising in treating patients with multiple sclerosis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of CIDP
  • on a stable dose of immunotherapy for at least 3 months before enrolling in the study

排除标准

  • myelopathy or evidence of central demyelination
  • persistent neurological deficits from stroke, CNS trauma, or peripheral neuropathy from other causes (eg, diabetes mellitus, IgM, paraproteinaemia, or uraemic, toxic, or familial neuropathy)
  • evidence of systemic disease that might cause neuropathy
  • heart diseases (congestive heart failure or arrhythmia)
  • pulmonary conditions (asthma or CIPD)
  • rheumatoid conditions (such as rheumatoid arthritis)
  • renal failure

研究组 & 干预措施

Lipoic acid

Active Comparator

alpha lipoic acid

干预措施: lipoic acid (Drug)

Placebo

Placebo Comparator

sugar pill

干预措施: lipoic acid (Drug)

结局指标

主要结局

Muscle Strength

时间窗: 16 weeks

次要结局

  • Hughes Functional Disability Scale(16 weeks)
  • Forced Vital Capacity (FVC)(16 weeks)
  • Motor Nerve Conduction Studies (NCS)(16 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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